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CRANEX® 3D
Digital Panoramic X-Ray System
User Manual
206718 rev. 5
CRANEX® 3D
Copyright
Code: 206718 rev 5 Date: April 17, 2013
Copyright © 4/17/13 by SOREDEX.
All rights reserved.
SOREDEX®/SCANORA®/CRANEX®
are
registered
trademarks of SOREDEX, PaloDEx Group Oy.
U.S. patents US6731717, US6829326 and USRE41197.
Finnish patents 114383.
Documentation, trademark and the software are
copyrighted with all rights reserved. Under the copyright
laws the documentation may not be copied, photocopied,
reproduced, translated, or reduced to any electronic
medium or machine readable form in whole or part, without
the prior written permission of SOREDEX.
The original language of this manual is English.
SOREDEX reserves the right to make changes in
specification and features shown herein, or discontinue the
product described at any time without notice or obligation.
Contact your SOREDEX representative for the most
current information.
Manufacturer
SOREDEX, PaloDEx Group Oy
Nahkelantie 160 (P.O. Box 148)
FI-04300 Tuusula
FINLAND
Tel. +358 10 270 2000
Fax. +358 9 701 5261
For service, contact your local distributor.
CRANEX® 3D
Table of Contents
1
Introduction.................................................................................................................. 1
1.1 CRANEX® 3D........................................................................................................ 1
1.2 References............................................................................................................ 2
1.3 Intended use ......................................................................................................... 2
1.4 Associated documentation .................................................................................... 3
1.5 Abbreviations used in this manual ........................................................................ 3
1.6 Warnings and precautions .................................................................................... 4
1.6.1 Warnings to be observed during use ......................................................... 4
1.6.2 Warnings for cross infection....................................................................... 5
1.6.3 General warnings ....................................................................................... 6
1.7 Disclaimer ............................................................................................................. 8
1.8 Disposal ................................................................................................................ 8
2
Unit description ........................................................................................................... 9
2.1 Main parts and controls......................................................................................... 9
2.2 Patient positioning lights ..................................................................................... 12
2.3 Patient positioning panel ..................................................................................... 15
2.3.1 Cephalometric unit ................................................................................... 15
2.4 Emergency stop switch ....................................................................................... 16
3
Imaging programs ..................................................................................................... 17
3.1 Panoramic programs........................................................................................... 17
3.2 Cephalometric programs..................................................................................... 20
3.3 3D programs ....................................................................................................... 22
3.4 Exposure settings for 3D imaging ....................................................................... 23
3.4.1 SMAR™, SOREDEX® Metal Artifact Reduction....................................... 24
4
Controlling the unit.................................................................................................... 25
4.1 ClearTouch™ control panel ................................................................................ 25
4.2 Modality section .................................................................................................. 26
4.3 Sectional imaging................................................................................................ 26
4.4 Automatic Exposure setting (AES)...................................................................... 27
4.4.1 AES values for Panoramic imaging.......................................................... 27
4.4.2 AES values for Cephalometric imaging.................................................... 28
4.4.3 Exposure indicators and settings ............................................................. 29
4.5 Status section...................................................................................................... 29
4.6 Other sections ..................................................................................................... 30
5
Using the unit............................................................................................................. 31
5.1 Attaching and removing the sensor..................................................................... 31
5.1.1 Attaching the sensor ................................................................................ 32
5.1.2 Removing the sensor ............................................................................... 33
5.2 Preparing the system .......................................................................................... 33
5.3 Panoramic exposures ......................................................................................... 34
5.3.1 Positioning devices .................................................................................. 34
5.3.2 General instructions ................................................................................. 35
5.3.3 Patient positioning.................................................................................... 37
5.3.3.1 Panoramic exposure.................................................................. 37
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5.3.3.2 TMJ exposure ............................................................................ 41
5.3.3.3 Maxillary Sinus exposure........................................................... 44
5.3.3.4 Taking the exposure .................................................................. 46
5.4 Cephalometric exposures ................................................................................... 48
5.4.1 General instructions ................................................................................. 48
5.4.2 Patient positioning.................................................................................... 50
5.4.2.1 Full width and reduced width projection..................................... 50
5.4.2.2 PA projection ............................................................................. 53
5.4.2.3 Reverse towne projection .......................................................... 55
5.4.2.4 Waters view ............................................................................... 57
5.4.2.5 Carpus program (optional)......................................................... 59
5.4.2.6 Taking the exposure .................................................................. 61
5.5 3D exposures ...................................................................................................... 63
5.5.1 Positioning devices .................................................................................. 63
5.5.2 General instructions ................................................................................. 64
5.5.3 Scout image ............................................................................................. 68
5.5.4 3D image.................................................................................................. 70
5.5.5 Stone model and radiographic guide scan............................................... 71
5.6 Warnings and error messages ............................................................................ 73
5.6.1 Acknowledging errors............................................................................... 73
5.6.2 Image transfer errors................................................................................ 73
6
Troubleshooting ........................................................................................................ 75
6.1 Patient positioning............................................................................................... 75
6.2 Image appearance .............................................................................................. 78
6.3 Artefacts .............................................................................................................. 79
6.4 Unit operation...................................................................................................... 81
7
Maintenance ............................................................................................................... 83
7.1 Maintenance procedure ..................................................................................... 83
7.1.1 Annual maintenance ................................................................................ 83
7.1.2 Calibration intervals.................................................................................. 83
7.2 Changing the fuses ............................................................................................. 84
7.3 Cleaning and decontaminating the unit............................................................... 84
8
Calibration and adjustment ...................................................................................... 87
8.1 Introduction ......................................................................................................... 87
8.2 Preparing for calibration ...................................................................................... 88
8.3 Panoramic calibration.......................................................................................... 89
8.3.1 Panoramic geometry calibration............................................................... 89
8.3.2 Panoramic pixel calibration ...................................................................... 90
8.3.3 Panoramic Quality Check (optional)......................................................... 91
8.4 3D calibration ...................................................................................................... 93
8.4.1 3D geometry calibration ........................................................................... 93
8.4.2 3D pixel calibration................................................................................... 94
8.4.3 3D Quality Check program....................................................................... 95
8.5 Cephalometric calibration.................................................................................... 97
8.5.1 Ceph pixel calibration............................................................................... 97
8.5.2 Ceph Quality check program (Optional)................................................... 98
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Technical data.......................................................................................................... 101
9.1 Technical specifications .................................................................................... 101
9.2 Unit dimensions................................................................................................. 112
9.3 Symbols that appear in the unit......................................................................... 113
9.4 Labels on the unit.............................................................................................. 115
9.5 Electromagnetic Compatibility (EMC) tables..................................................... 116
9.6 X-ray tube assemblies....................................................................................... 121
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1
Introduction
1.1 CRANEX® 3D
CRANEX® 3D is a dental x-ray system for
producing high quality digital images of dentition, TM-joints
and skull. In order to take images with CRANEX® 3D you
need a suitable PC hardware connected to the CRANEX®
3D unit and SCANORA® software to capture and manage
images.
CRANEX® 3D performs the following procedures:
Panoramic
•
Adult panoramic
•
Child panoramic (Reduced width and height)
•
Bitewing
•
TMJ, PA projection
•
TMJ, lateral projection (axially corrected)
•
Maxillary sinus
Cephalometric (optional)
•
Cephalometric Full size Lateral
•
Cephalometric Reduced size lateral
•
Cephalometric posterior-anterior projection PA/AP
•
Reverse Towne projection
•
Waters view
•
Carpus program (optional)
(Not available in USA and Canada)
3D (optional)
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XS 61x41 mm Field of View
•
Midi 61x78 mm Field of View
•
Endo 61 x 41 mm Field of View
SOREDEX
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1 Introduction
1.2 References
The following instructions are delivered with in the
CRANEX® 3D installation manual:
•
Firmware update instructions
•
Calibration instructions
•
Cephalostat upgrade instructions
•
Cephalostat side changing instructions
The following instructions are separate and can be ordered
from customer service:
•
3D upgrade instructions are delivered with the 3D
upgrade kit
1.3 Intended use
CRANEX® 3D must only be used and operated by dentist
and other qualified professionals. CRANEX® 3D must only
be used to take panoramic, cephalometric and 3D images
of the dento-maxillofacial complex of the human skull. It
must not be used to take images of any other part of the
human body.
Panoramic and 3D exposures should not be used if
conventional intraoral radiographic images (bitewing
exposures) would be sufficient.
Cone beam computed tomography images are not
adequate for the analysis of soft tissue.
CAUTION! USA only: Federal law restricts this device to
sale by or on the order of a dentist or other qualified
professional.
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1.4 Associated documentation
•
CRANEX® 3D user manual
•
CRANEX® 3D installation manual
•
The SCANORA® software user manual
•
The SCANORA® software installation manual
•
The user manual supplied with the dental imaging
software
•
The installation manual supplied with the dental
imaging software
•
The user manual supplied with the 3D imaging
software
•
The installation manual supplied with the 3D
imaging software
1.5 Abbreviations used in this manual
FOV = Field Of View. The cylindrical 3D volume that is
reconstructed by the system.
ROI = Region Of Interest. The anatomical area or region of
the patient that you are interested to examine.
AES = Automatic Exposure Setting
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1 Introduction
1.6 Warnings and precautions
1.6.1
Warnings to be observed during use
The unit may be dangerous to the user and the patient, if
the safety regulations in this manual are ignored, if the unit
is not used in the way described in this manual and/or if the
user does not know how to use the unit.
The unit must only be used to take the dental x-ray
exposures described in this manual. The unit must NOT be
used to take any other x-ray exposures. It is not safe to use
the unit to take x-ray exposures, that it is not designed for.
Only professionally qualified dental and/or medical
personnel are allowed to operate the unit and carry out any
diagnoses based on output from the unit.
Because the x-ray limitations and safety regulations
change from time to time, it is the responsibility of the user
to make sure that all the valid safety regulations are
fulfilled.
When taking an x-ray exposure of a patient with
exceptional anatomy (typically very tall or large) use the
Test-mode (no x-rays) first to make sure that patient can
be positioned correctly to the unit and for checking that the
unit doesn't hit the patient.
Operator should maintain visible contact with the patient
and technique factors. This allows immediate termination
of radiation by the release of the exposure button in the
event of a malfunction or disturbance.
It is the responsibility of the doctor to decide whether x-ray
exposure or any additional exposures are justified and
necessary.
The minimum height of patient that can be x-rayed is 120
cm (3.9ft / 47.2in) and the maximum is 200 cm (6ft /78in).
These heights only apply to patients with normal anatomy.
Always use the lowest suitable x-ray dose to obtain the
desired level of image quality.
Avoid taking x-ray exposures of pregnant women.
When taking an x-ray exposure of a child always use the
lowest possible x-ray dose, the smallest possible image
area and the lowest possible resolution that allows you to
perform the required diagnostic task.
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1 Introduction
If the patient is using a pacemaker, consult the
manufacturer of the pacemaker before taking an exposure
to confirm that the x-ray unit will not interfere with the
operation of the pacemaker.
Decontaminate all the surfaces that the patient is in contact
with after every patient to prevent cross infection.
Decontaminate all device accessories that contact the
patient during a radiographic examination.
Do not open or remove any of the unit’s enclosures. No
user serviceable parts inside.
The customer must ensure that the siting environment
fulfills the requirements listed in the Installation manual.
Special attention must be paid to the strength of the floor
and wall materials, electrical mains and radiation
protection. It is the responsibility of the customer to ensure
that the site is large enough for the patients.
The unit contains toxic materials that need to be handled
properly when disposing the unit. Return the unit to the
dealer in the end of its life cycle.
Excessive dust should be cleaned from the unit for free
airflow and cooling. Switch of the unit before cleaning.
Always follow the instructions for patient positioning and
imaging procedures instructed in the User Manual.
1.6.2
Warnings for cross infection
Always use available disposable protective covers with the
patient positioning accessories:
Bite block cover
Chin plane cover
TMJ support cover
Lip holder cover
Chin cup cover
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1.6.3
General warnings
Personnel operating the device must be adequately trained
with respect to the technological principles of operation
and radiation protection when using cone beam computed
tomography (CBCT) imaging.
This unit complies with the EMC (Electromagnetic
Compatibility) according to IEC 60601-1-2. Radio
transmitting equipment, cellular phones etc. shall not be
used in close proximity of the unit as they could influence
the performance of the unit.
The correct software and settings in the workstation are
essential to the performance of the unit. Consult technical
support to ensure correct setup.
Danger: Explosion hazard - do not use in the presence of
flammable anesthetics, gases or vapors.
The unit is factory set to operate using a 230-240 ±10 VAC
power supply. Never connect the unit to a power supply
different to the voltage marked on the unit.
The site must fulfill the environmental requirements in the
installation manual chapter technical specifications.
There should be free space around the unit for safe
operation.
To maintain patient safety it is mandatory to
unshielded CAT6 Ethernet cable between the unit
network or workstation, so that multiple chassis
connected. Non-medical grade PC should not be
patient environment.
use an
and the
are not
used in
This product itself complies with IEC 60601-1 medical
safety standard but in order to the system incorporating
also a PC to comply the standard, EITHER the PC has to
be a medical PC OR the PC has to be located over 1,5
meters apart from the unit. The installer and the user of the
system shall confirm that at least one of the above
requirements is fulfilled. A PC is a medical one if it
complies IEC 60601-1 standard and that is indicated in the
accompanying documents of the PC. See chapter
Technical specifications, Minimum PC Requirements, in
user manual.
All service operations must be made by authorized service
personnel only.
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1 Introduction
The annual service as described in manual is mandatory
for the correct and safe operation of the unit.
When taking exposures, operators and service personnel
must protect themselves from radiation and remain at least
two meters (six feet) away from the unit during exposure.
Protect the patient from scattered radiation by placing a
protective lead apron over the patient.
The unit must be installed and serviced according to the
unit Installation & adjustments manual by a qualified
technician.
Only personnel trained and approved by the manufacturer
of the unit are allowed to service the unit.
3D should not be used for routine or screening
examinations in which a radiograph is taken regardless of
the presence or absence of clinical signs and symptoms.
3D imaging examinations must be justified for each patient
to demonstrate that the benefits outweigh the risks.
Where it is likely that evaluation of soft tissues will be
required as part of the patient’s radiological assessment,
the imaging should be done using conventional medical CT
or MR, rather than 3D imaging using Cone Beam
technology.
Make sure that patient’s thyroid glands are protected by a
lead apron during the exposure.
The place where the unit is to be installed and the position
from where the user will take exposures must be correctly
shielded from the radiation that is generated when the unit
is operated. Ensure to fulfill or exceed the requirements of
your local regulations.
The unit or its parts must not be changed or modified in
any way without approval and instructions from the
manufacturer.
When servicing use only approved replacement parts
supplied by the manufacturer.
The use of accessories not complying with the equivalent
safety requirements of this equipment may lead to a
reduced level of safety of the resulting system.
If this device is used with 3rd party imaging application
software not supplied by the manufacturer, the 3rd party
imaging application software must comply with all local
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1 Introduction
laws on patient information software. This includes the
Medical Device Directive 93/42/EEC and/or relevant legal
requirements in the USA.
Do not connect any equipment to the unit that has not been
supplied with the unit or that is not recommended by the
manufacturer. The use of accessory equipment not
complying with the equivalent safety requirements of this
equipment may lead to a reduced level of safety of the
resulting system.
Mirror shall be closed before taking exposures.
1.7 Disclaimer
The manufacturer shall have no liability for consequential
damages, personal injury, loss, damage or expense
directly or indirectly arising from the use of its products. No
agent, distributor or other party is authorized to make any
warranty or other liability on behalf of the manufacturer with
respect to its products.
1.8 Disposal
The device, its spare parts, its replacement parts and its
accessories may include parts that are made of or include
materials that are non-environmentally friendly or
hazardous. These parts must be disposed of in
accordance with all local, national and international
regulations regarding the disposal of non-environmentally
friendly or hazardous materials.
Unit has at least the following parts that should be
regarded as nonenvironmental friendly waste products:
■
■
■
■
8
Tubehead (Pb, oil)
Collimator (Pb)
All electronic circuits, electronic boards inside
Sensor covers (EMC painted)
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Unit description
2.1 Main parts and controls
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2 Unit description
1. Column
2. Carriage
3. Main support
4. Rotating unit
5. On / off switch (rear of carriage) and main fuses
6. Tubehead assembly
7. ClearTouch™ control panel
8. Positioning panel
9. Sensor head
10.Head support
11.Chin rest
12.Handles
13.Cephalometric unit
14.Cephalometric sensor
15.Secondary collimator
16.Positioning panel
Fig 1.1.
On/off switch and main fuses
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PC with MDD approved dental imaging software and 3D
viewing software (not included).
All software must conform to the MDD and the relevant
legal requirements in the USA.
The PC must conform to all the unit and dental imaging
software requirements.
1. Sensor holder (PAN units only)
2. Panoramic sensor
1. 3D sensor (units with 3D option)
2. Panoramic sensor
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2 Unit description
2.2 Patient positioning lights
1. Midsagittal
2. Frankfort-horizontal
3. Focal trough
4. Cephalometric Frankfort horizontal
5. Horizontal, top of FOV (3D option only)
6. Horizontal, bottom of FOV (3D option only)
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2 Unit description
Panoramic lights
1. Midsagittal light
2. Frankfort-horizontal plane
1. Focal through light
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2 Unit description
Cephalometric lights
1. Frankfort-horizontal plane
3D lights
1. Midsagittal light
2. Horizontal light, top of FOV
3. Horizontal (H) light, bottom of FOV
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2 Unit description
2.3 Patient positioning panel
1. Carriage UP/DOWN (Z-movement)
2. Focal through adjustment (Y-movement)
3. Positioning lasers ON/OFF
4. Return
5. Chin support UP/DOWN
2.3.1
Cephalometric unit
1. Carriage down
2. Carriage up
3. Positioning lights ON/OFF
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2 Unit description
2.4 Emergency stop switch
In case of malfunction of the exposure button or other
protective devices of the unit, an emergency stop switch is
provided near the handles and on the roof of the
cephalostat head so that the patient can reach it.
If the emergency stop switch is pressed during an
exposure, the exposure is terminated immediately and the
x-ray unit is completely stopped. An interrupted exposure
cannot be continued later, but has to be retaken from the
beginning.
Press to stop the unit, rotate to release.
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Imaging programs
3.1 Panoramic programs
Adult: Magnification 1.3
Panoramic imaging provides general view of dental and
facial anatomy based on panoramic imaging technic.
Adult panoramic 20,5 cm width x 11 cm
height.
Child: Magnification 1.3
Child panoramic 11,5 cm width x 8,5 height.
Child panoramic has reduced width and height. Children
can be imaged with less radiation dosage and shorter
exposure time. Patients with jaw more narrow than
average jaw can be exposed with this too.
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3 Imaging programs
Bitewing: Magnification 1.3
An orthogonal view of the dentition from the canine and
posterior.
Lateral TMJ: Magnification 1.23
a
b
Lateral TMJ program provides a wide layer axially
corrected views for the patient's left and right
temporomandibular joints.
PA TMJ: Magnification 1.55
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3 Imaging programs
Maxillary Sinus: Magnification 1.3
Mesial 10 mm
Start
Distal 10 mm
Maxillary Sinus program produces a pan - tomographic
layer through the posterior maxillary sinus. The layer is
flatter than the standard panoramic programs and is
moved 18 mm backward. These images are helpful in
visualizing the mid and posterior maxillary sinus.
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3 Imaging programs
3.2 Cephalometric programs
Cephalometric programs provide central projection images
of patient skull and dental anatomy. Images are utilized in
ortodontics and general diagnostics.
Full size lateral: Magnification 1.15
Field size: 22 x 26 cm (height x wide).
Lateral Cephalostat uses a full height
image field.
Reduced size lateral
Field size: 22 x 18 cm (height x wide).
Reduced Width Lateral program has an
optimized image width that is used e.g. for pediatric
patients but also adult patients to reduce the radiation
dose.
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3 Imaging programs
Cephalometric posterior-anterior (PA):
Magnification 1.15
PA 22 x 20 cm (height x wide)
Carpus program (optional)
(Not available in USA and Canada)
Requires separate holder, not part of standard
delivery.
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3 Imaging programs
3.3 3D programs
Cone beam 3D imaging enables seeing dentomaxillofacial
anatomy of selected Field of View, FOV, helping with
diagnostics and treatment planning. With 3D viewing
software, user is able to analyze FOV area from multiple
directions and see cross-sectional images from the area of
interest.
XS FOV 61 x 41 mm (height x diameter)
High resolution (133μm voxel size)
Standard resolution (200μm voxel size)
Endo FOV 61 x 41 mm (height x diameter)
Program for optimized endodontic imaging.
Endo program (85µm voxel size)
Midi size FOV 61 x 78 mm (OPTIONAL)
Standard resolution or High resolution.
High resolution (200μm voxel size)
Standard resolution (300μm voxel size)
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3 Imaging programs
3.4 Exposure settings for 3D imaging
Exposure settings for 3D imaging
Note! Voltage settings is always 90kV with unit 3D modality.
Resolution
FOV
(h x w)
Exposure
time
Scanning Amount
mA
time
of projec- Low dose
tions
(DAP
mGycm2)
High Res 61 x 41 mm
6,1 s
10 s
608
Std Res
61 x 41 mm
2,3 s
10 s
230
High Res 61 x 78 mm
12,6 s
20 s
1260
Std Res
4,9 s
20 s
460
61 x 78 mm
6.3 mA
(298)
8 mA
(145)
5 mA
(491)
8 mA
(302)
mA
Highquality
(DAP
mGycm2)
8 mA
(379)
10 mA
(181)
6.3 mA
(619)
10 mA
(372)
mA
Highquality
(DAP
mGycm2)
13 mA
(593)
13 mA
(227)
10 mA
(983)
13 mA
(472)
DAP values vary from unit to unit in relation to the x-ray
tube output. Thus above values indicate average DAP
values. In addition to these recommended values, there is
a possibility to use the whole mA range if the user prefers.
Available mA ranges for each field of view sizes and resolution settings
Resolution
FOV
4 mA
5 mA 6.3 mA 8 mA 10 mA 13 mA
(h x w)
Endo program 61 x 41 mm
x
x
x
x
x
x
High Res
61 x 41 mm
x
x
x
x
x
x
Std Res
61 x 41 mm
x
x
x
x
High Res
61 x 78 mm
x
x
x
x
x
Std Res
61 x 78 mm
x
x
x
x
Exposure settings for scout imaging (default values)
Resolution
FOV
kV
mA
Scan(h x w)
ning
time
Scout
61 x 41 mm
90
13
0,02 s
Scout
61 x 78 mm
90
13
0,04 s
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3 Imaging programs
3.4.1
SMAR™, SOREDEX® Metal Artifact
Reduction
SMAR™, SOREDEX® Metal Artifact Reduction software
can be used to reduce the effect of metals and other dense
radiopaque objects on the 3D image. These create
artifacts that are seen typically as stripes and shadows
from the above-mentioned objects. To utilize SMAR™ on a
3D image may have affect to image reconstruction time
SMAR™-button is ON. SMAR™-button becomes visible
on the 3D modality.
SMAR™-button is OFF.
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Controlling the unit
4.1 ClearTouch™ control panel
1. Modality selection
2. Program selection
3. Imaging values
4. Imaging area
5. Status of the unit
6. Test mode
7. Settings
8. Case end
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4 Controlling the unit
4.2 Modality section
Select the modality button PAN, CEPH or 3D.
When panoramic modality is selected, a program specific
dental arch is shown. This can be used for partial
panoramic imaging.
Cephalometric programs have their own, program specific
model heads and setting buttons for the start position of
lateral scanning.
3D programs (two FOV sizes) have buttons for selecting
low resolution, high resolution or scout image mode. The
FOV for 3D imaging can be positioned on the XY-plane by
selecting the center point of the FOV on the dental arch of
the touch screen display. The FOV is positioned in the Zdirection by using the chin rest movement and positioning
lights.
4.3 Sectional imaging
Dental arch on the touch panel shows the enabled and
disabled arch sections from the result point of view. Select
the image area from the dental arch.
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4 Controlling the unit
4.4 Automatic Exposure setting (AES)
AES automatically recommends the exposure values
according to the size of the patient’s head in panoramic
and cephalometric imaging. The AES is activated with
active A button and by pushing Return button once. The
AES suggest exposure values based on patient size. The
user can change the value before exposure if needed by
pushing A button again and changing the values.
4.4.1
AES values for Panoramic imaging
Note! Values can be re-scaled by SOREDEX authorized
service personnel.
Adult, child panoramic, Bitewing, Sinus
Head width (min)
kV
mA
19,3 cm (Max)
70
13
15,9 cm
70
10
14,2 cm
70
8
13,35 cm
66
8
12,925 cm
66
6,3
12,5 cm (Min)
66
5
AES values for TMJ Lat/PA
Head width (min)
kV
mA
19,3 cm (Max)
73
16
15,9 cm
73
13
14,2 cm
73
10
13,35 cm
73
8
12,925 cm
73
6,3
12,5 cm (Min)
73
5
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SOREDEX
27
4 Controlling the unit
4.4.2
AES values for Cephalometric imaging
Lat/PA 100 V
Head width (min)
kV
mA
17,3 cm (Max)
90
8
14,45 cm
90
8
12,65 cm
90
8
11,45 cm
90
8
10,55 cm
90
8
6,5 cm (Min)
85
8
28
s
20
20
16
12,5
10
10
Ceph Lat/PA 120 V
Head width (min)
kV
mA
17,3 cm (Max)
90
10
14,45 cm
90
10
12,65 cm
90
10
11,45 cm
90
10
10,55 cm
90
10
6,5 cm (Min)
85
8
20
20
16
12,5
10
10
Ceph Lat/PA 240 V
Head width (min)
kV
mA
17,3 cm (Max)
90
12,6
14,45 cm
85
12,6
12,65 cm
85
12,6
11,45 cm
85
12,6
10,55 cm
85
10
6,5 cm (Min)
85
8
16
16
12,5
10
10
10
SOREDEX
s
s
206718 rev 5
4 Controlling the unit
4.4.3
Exposure indicators and settings
kV value
mA value
Exposure time (s)
Dose value (mGycm2)
Focal through light (mm)
Focal through light
y-layer position
Test mode
Automatic Exposure setting
(AES)
4.5 Status section
Status field shows when the unit is ready for capturing or
any trouble occurs. Green or red color indicate the status in
question. Green means ready to capture and red means
not ready. During actual exposure, a large radiation
warning symbol will fill the display area.
Ready for imaging
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29
4 Controlling the unit
4.6 Other sections
General settings
■
Info
- System IP address and other system related data
■
Languages
- Use this to select language on the touchscreen
■
Service
- Use this to reach the programs for periodical
maintenance
■
Retrieve Last Image
- Use this to retrieve the last image from the device
memory e.g. after a system crash
- Please make sure that the retrieved image is associated with the correct patient
■
Retrieve With SMAR™
- After taking a 3D image with SMAR™ either on or
off, image can be re-reconstructed with different
setting by selecting either “Retrieve last image” or
“Retrieve With SMAR™” from the general settings
on the touch screen. If reconstruction with SMAR™
is unavailable for the last captured image, e.g. last
taken image is cephalometric, “Retrieve With
SMAR™”-button will not be visible.
NOTE! Only the last taken x-ray image is saved in
the unit until the power is switched off. This image
data is used in the retrieve procedure.
30
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5
Using the unit
5.1 Attaching and removing the sensor
Note! The pixel calibration results are sensor specific. If the
x-ray unit is equipped with separate panoramic and cephalometric sensors, the cephalometric sensor cannot be used
for panoramic imaging without re-calibration (and vice versa).
Re-do panoramic pixel calibration, if cephalostat sensor ismoved to panoramic side or the sensor is changed.
WARNING!
Handle the sensor with care as instructed in this
manual. The sensor must not be dropped or
exposed to impacts. A shock indicator inside the
sensor shows if the sensor has been exposed to
excess impact.
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5 Using the unit
5.1.1
Attaching the sensor
1. Insert the four slots on the rear of the sensor, into the four
hooks in the sensor holder.
2. Slide the sensor downwards until it stops and then slide
the locking knob down on the side of the sensor to lock
the sensor in position.
32
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5 Using the unit
5.1.2
Removing the sensor
1. Slide the locking knob upwards on the side of the sensor
to unlock the sensor.
2. Slide the sensor up and remove it.
5.2 Preparing the system
1. Switch on the unit and the PC.
2. PC: Start SCANORA® software (or 3rd party application).
3. PC: Open a new or existing patient or select a patient
from the worklist. See the user’s guide supplied with the
dental imaging program.
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5 Using the unit
5.3 Panoramic exposures
■
■
■
■
■
■
5.3.1
Bite block
Chin rest holder
34
Adult panoramic
Child panoramic (Reduced width and height)
Bitewing
Maxillary sinus
TMJ, PA/AP projection
TMJ, lateral projection (axially corrected)
Positioning devices
Chin plane
TMJ support
Lip holder for
edentulous patients
Chin cup
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206718 rev 5
5 Using the unit
5.3.2
General instructions
1. PC: Click Image Capture.
2. Select panoramic imaging.
3. Select the imaging program.
4. Any section of the dental arc can be selected for the sectional imaging to limit exposure area and reduce the radiation dosage.
5. Press the Return button to rotate the unit to ‘patient in’
position.
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5 Using the unit
6. Open the temple supports.
1 Temple support knob
2 Forehead support
3 Temple supports
7. Ask the patient to remove any spectacles, hearing aids,
removable dentures, jewellery and hair clips and pins.
Place a protective lead apron on the patient.
36
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5 Using the unit
5.3.3
Patient positioning
5.3.3.1
Panoramic exposure
1. Insert the chin rest and bite rod with the bite block. Place
the disposable covers.
Note! Use a new disposable cover for every patient.
2. Adjust the unit height.
3. Guide the patient to the unit and instruct to stand as
straight and tall as possible. Exposure can be taken also
in sitting position. Ask the patient to take grip on the handles and bite on the bite block. Use the lipholder or the
chin support for an edentulous patient.
Figure 1.1 bite block and lip holder
4. Ask the patient to take one step forward to straighten the
spinal column. Patient is slightly leaning backwards during the imaging.
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5 Using the unit
5. Check the position of the midsagittal light. If it is not on
the midsagittal plane of the patient, adjust the patient’s
head.
Make sure the patient’s head is not turned or tilted.
6. Adjust the height of the Frankfort-Horizontal plane (FH)
laser to get the laser light over the orbita porion. Straighten the patient's head if needed.
38
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5 Using the unit
7. Close the temple supports by sliding the temple support
knob to the right (A). Adjust the position of the nasion
support (B) and push the forehead support in until it
touches the patient’s nasion (C).
8. The focal trough light indicates the center of the focal
trough, which is 10 mm wide at the front. The root apices
of the patient’s central upper and lower front incisors
must be within the focal trough.
Ask the patient to open their lips so that you can see their
teeth. The focal trough light should be positioned slightly
in front of the root apices, which for most patients will be
in the middle of 3rd tooth (canine).
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SOREDEX
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5 Using the unit
If the patient is edentulous the focal trough light should
be approximately 5mm behind the lip holder when the
focal trough position is 0 mm.
Note! If the focal trough light is not positioned as described above, press the focal trough adjustment
key(s) to move the focal trough light until it is positioned correctly.
Figure 1.2 Focal trough light position indicator
9. If AES is enabled (green light lit around "A"), press the
Return button and wait for the movement to finish. Verify
that the suggested exposure values are suitable for the
patient. If AES is disabled, set the exposure values manually and press Return to drive the unit into exposure
start position (optional).
10.Ask the patient to press their tongue against the roof of
their mouth, swallow and remain still for the duration of
the exposure.
40
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206718 rev 5
5 Using the unit
5.3.3.2
TMJ exposure
1. Insert the required positioning devices, including the TMJ
support. Place the disposable covers.
Note! Use a new disposable cover for every patient.
2. Adjust the unit height.
3. Guide the patient to the unit and instruct to stand as
straight and tall as possible. Ask the patient to take grip
on the handles and set the mouth against the lip holder.
4. TMJ lateral projection: Adjust the height of the FrankfortHorizontal plane (FH) laser to get the laser light over the
orbita porion. Straighten the patient's head if needed.
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5 Using the unit
5. TMJ PA/AP projection: Tilt the patient’s head forward.
6. Check the position of the midsagittal light. If it is not on
the midsagittal plane of the patient, adjust the patient’s
head.
7. Close the temple supports by sliding the temple support
knob to the right. Adjust the position of the nasion support and push the forehead support in until it touches the
patient’s nasion.
42
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206718 rev 5
5 Using the unit
8. Adjust the position of the TMJ light until it aligns in the
middle of condyle.
Note! The condyle moves forward by approximately
10 mm when the mouth is opened"
9. If AES is enabled (green light lit around "A"), press the
Return button and wait for the movement to finish. Verify
that the suggested exposure values are suitable for the
patient. If AES is disabled, set the exposure values manually and press Return to drive the unit into exposure
start position (optional).
10.Ask the patient to press their tongue against the roof of
their mouth, swallow and remain still for the duration of
the exposure.
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SOREDEX
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5 Using the unit
5.3.3.3
Maxillary Sinus exposure
1. Insert the the lip holder for sinus imaging.
Place the disposable covers.
Note! Use a new disposable cover for every patient.
2. Adjust the unit height.
3. Guide the patient to the unit and instruct to stand as
straight and tall as possible. Ask the patient to take grip
on the handles and set the mouth against lip holder.
4. Check the position of the midsagittal light. If it is not on
the midsagittal plane of the patient, adjust the patient’s
head.
5. Adjust the height of the Frankfort-Horizontal plane (FH)
laser to get the laser light over the orbita porion. Straighten the patient's head if needed.
6. Close the temple supports by sliding the temple support
knob to the right. Adjust the position of the nasion support and push the forehead support in until it touches the
patient’s nasion.
44
SOREDEX
206718 rev 5
5 Using the unit
7. Adjust the position of the image layer as necessary. The
focal trough light should be positioned in the middle of
the 3rd tooth or if wanted slightly posterior.
Note! If the focal trough light is not positioned as described above, press the focal trough adjustment
key(s) to move the focal trough light until it is positioned correctly.
8. If AES is enabled (green light lit around "A"), press the
Return button and wait for the movement to finish. Verify
that the suggested exposure values are suitable for the
patient. If AES is disabled, set the exposure values manually and press Return to drive the unit into exposure
start position (optional).
9. Ask the patient to press their tongue against the roof of
their mouth and remain still for the duration of the exposure.
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SOREDEX
45
5 Using the unit
5.3.3.4
Taking the exposure
WARNING!
Close the patient positioning mirror before taking
any exposures.
1. Ask the patient to remove any spectacles, dentures, jewellery and hair clips and pins. Place a protective lead
apron around the patient’s neck to protect the patient’s
thyroid gland from radiation.
2. Press Return. Check the patient positioning.
Protect yourself from radiation by standing behind a suitable x-ray radiation shield. Make sure that you can see
and hear the patient during the exposure.
Note! In all examinations the user of the x-ray equipment
should wear protective clothing. The operator does not
need to be close to the patient during normal use. The protection against stray radiation can be achieved by using the
hand switch not less than 2 m (7 ft) from the focal spot and
the xray beam. Operator should maintain visible contact
with the patient and Technical factors. This allows immediate termination of radiation by the release of the exposure
button in the event of a malfunction or disturbance.
Note! If the patient is nervous, or a child, you can demonstrate how the unit works to reassure them. Press the T
(Test mode) button and then press and hold the exposure
button. The unit will complete an exposure cycle without
generating x-rays.
46
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206718 rev 5
5 Using the unit
3. Press and hold down the exposure button. During the exposure you hear an audible signal and the exposure
warning symbol on the ClearTouch™ control panel appears.
The unit rotates around the patient’s head and stops.
When the rotating unit stops, the exposure has been taken.
4. After the exposure the rotating unit is in ‘patient out’ position, if the exposure switch has been pressed until all
movements have stopped. Release temple supports.
Guide the patient out. Remove disposable covers and
disinfect the unit.
5. PC: The image can be examined using the SCANORA®
software. See SCANORA® software user’s manual.
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5 Using the unit
5.4 Cephalometric exposures
■
■
■
■
■
■
Reduced Width lateral projection
Lateral projections
PA/AP projection
Reverse towne projection
Waters view
Carpus program (optional)
(Not available in USA and Canada)
WARNING!
Remove all calibration tools, Pan and 3D patient
positioning accessories before taking any
cephalomateric exposures!
5.4.1
48
General instructions
1.
Move the ceph sensor to the ceph sensor holder in a
case of single sensor configuration.
2.
PC: Click Image Capture.
3.
Select CEPH.
SOREDEX
206718 rev 5
5 Using the unit
206718 rev 5
4.
Select the imaging program.
5.
If AES is enabled (green light lit around "A"), press the
Return button and wait for the movement to finish. Verify that the suggested exposure values are suitable for
the patient. If AES is disabled, set the exposure values
manually and press Return to drive the unit into exposure start position (optional).
6.
Press Return to drive the unit to ‘patient in’ position.
7.
Ask the patient to remove any spectacles, hearing aids,
removable dentures, jewelry and hair clips and pins.
Place a protective lead apron on the patient.
SOREDEX
49
5 Using the unit
5.4.2
5.4.2.1
50
Patient positioning
Full width and reduced width projection
SOREDEX
206718 rev 5
5 Using the unit
1.
Unlock the lever and turn the ear rods to the lateral projection position. Lock the position.
2.
Place the disposable covers.
Note! Use a new disposable cover for every patient.
206718 rev 5
3.
Adjust the unit height.
4.
Guide the patient to the unit. Instruct the patient to
stand as straight and tall as possible under the cephalostat head. Slide the ear rods towards to patient’s ears.
Tall patients can also sit on a chair.
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5 Using the unit
5.
Adjust the patient head so that the Frankfort-Horizontal
plane (FH) and laser light are in same horizontal plane.
Note!
The shown laser line is a horizontal reference line.
6.
52
Slide nasion support against patient’s nasion.
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5 Using the unit
5.4.2.2
206718 rev 5
PA projection
SOREDEX
53
5 Using the unit
1.
Unlock the lever and turn the ear rods to the PA projection position. Lock the position. Tilt the nasion support
aside.
2.
Place the disposable covers.
Note! Use a new disposable cover for every patient.
54
3.
Adjust the unit height.
4.
Guide the patient to the unit facing the sensor. Instruct
the patient to stand as straight and tall as possible under the cephalostat head. Slide the ear rods towards
patient’s ears. Tall patients can also sit on a chair.
SOREDEX
206718 rev 5
5 Using the unit
5.4.2.3
Reverse towne projection
1.
Unlock the lever and turn the ear rods to the PA projection position. Lock the position. Tilt the nasion support
aside.
2.
Place the disposable covers.
Note! Use a new disposable cover for every patient.
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5 Using the unit
56
3.
Adjust the unit height.
4.
Guide the patient to the unit facing the sensor. Instruct
the patient to stand as straight and tall as possible under the cephalostat head.
5.
Turn the head ventral as reference to the canthomeatal
line about 30° below the horizontal plane.
6.
Slide the ear rods towards patient’s ears.
7.
Ask the patient open mouth maximally.
SOREDEX
206718 rev 5
5 Using the unit
5.4.2.4
Waters view
1.
Unlock the lever and turn the ear rods to the PA projection position. Lock the position. Tilt the nasion support
aside.
2.
Place the disposable covers.
Note! Use a new disposable cover for every patient.
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5 Using the unit
58
3.
Adjust the unit height.
4.
Guide the patient to the unit facing the sensor. Instruct
the patient to stand as straight and tall as possible under the cephalostat head.
5.
Turn the head torsal as reference to the canthomeatal
line about 35-40° above the horizontal plane.
6.
Slide the ear rods towards patient’s ears.
7.
Ask the patient open or close mouth.
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5 Using the unit
5.4.2.5
206718 rev 5
Carpus program (optional)
(Not available in USA and Canada)
SOREDEX
59
5 Using the unit
CAUTION!
Before taking Carpus image make sure this imaging
method is approved by local authorities of your
country.
1.
Unlock the lever and turn the ear rods to the PA projection position. Lock the position. Tilt the nasion support
aside. Place the carpus holder to the nasion support
holder.
2.
Adjust the unit height if needed.
3.
Ask the patient to remove rings and metal objects and
to place hand on the carpus holder.
Note! Carpus holder is a separate accessory. Order
from local distributor.
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5 Using the unit
5.4.2.6
Taking the exposure
WARNING!
Close the patient positioning mirror before taking
any exposures.
206718 rev 5
1.
Ask the patient to remove any spectacles, hearing aids,
removable dentures, jewellery and hair clips and pins.
Place a protective lead apron around the patient’s neck
to protect the patient’s thyroid gland from radiation.
2.
Protect yourself from radiation by standing behind a
suitable x-ray radiation shield. Make sure that you can
see and hear the patient during the exposure.
3.
Press and hold down the exposure button. During the
exposure you hear an audible signal and the exposure
warning symbol on the ClearTouch™ control panel appears.
4.
Release the ear rods and guide the patient out.
Remove disposable covers and decontaminate the
unit.
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5 Using the unit
5.
PC: The image can be examined using the SCANORA® software. See SCANORA® user manual.
Note! In all examinations the user of the x-ray equipment should wear protective clothing. The operator
does not need to be close to the patient during normal
use. The protection against stray radiation can be
achieved by using the hand switch not less than 2 m (7
ft) from the focal spot and the xray beam. Operator
should maintain visible contact with the patient and
technique factors. This allows immediate termination of
radiation by the release of the exposure button in the
event of a malfunction or disturbance.
1.
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5.5 3D exposures
5.5.1
Positioning devices
Chin cup
Bite block and chin plane
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5 Using the unit
5.5.2
General instructions
1. PC: Click Image Capture.
2. Select the 3D modality.
The teeth locations on the 3D dental arch
are approximate and are based on
average dentition. The exact teeth
locations will depend on the patient’s
individual anatomy.
The EasyScout function helps locate the
correct dental location of the Field of view.
3. Select the Field Of View (FOV):
XS FOV 61 x 41 mm (Program 1)
Endo program FOV 61 x 51 mm
Midi FOV 61 x 78 mm (Program 2) (OPTIONAL)
4. Select the area of interest on the dental arch. The 3D
FOV is positioned more accurately by using the scout image mode. The area of interest can be adjusted on the
ClearTouchTM control panel after the scout image has
been taken.
5. Press Return to rotate the unit to ‘patient in’ position.
64
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5 Using the unit
6. Adjust the unit height.
7. Ask the patient to remove any spectacles, hearing aids,
removable dentures, jewellery and hair clips and pins.
8. Guide patient to the unit. Instruct patient to stand as
straight and tall as possible next to the unit. Patient can
also be imaged in sitting position. Ask the patient to take
grip on the handles and place chin on the chin cup.
9. Check the position of the midsagittal light. If it is not on
the midsagittal plane of the patient, adjust the patient’s
head.
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5 Using the unit
10.Adjust the unit height and chin rest height to get the area
of interest between the top and bottom FOV lights. Position the patient so that the occlusal plane is horizontal.
1.Horizontal light, top of FOV
2.Horizontal light, bottom of FOV
Note! Target ROI is always in the middle plane of laser lights.
11.Select the image area from the dental arch.
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12.Close the temple supports by sliding the temple support
knob to the right (A). Adjust the position of the nasion
support (B) and push the forehead support in until it
touches the patient’s nasion (C).
13.Select
A the Scout image
or
B the Standard
or
C High resolution 3D image
or
D Endo program
A
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SOREDEX
B
C
D
67
5 Using the unit
5.5.3
Scout image
WARNING!
Close the patient positioning mirror before taking
any exposures.
1. Press and hold down the exposure button. During the exposure you hear an audible signal and the exposure
warning symbol on the ClearTouchTM control panel appears.
2. Scout preview image appears to the ClearTouch™ control panel.
3. Fine adjust scout position using the side arrow keys.
Press the left lower corner icon to continue.
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5 Using the unit
4. Take a new scout or
save current and continue to 3D image.
5. Previous FOV position is shown as gray circle and new
position is showed as green circle.
Note! Gray circles remain in control panel until you change
the patient.
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5 Using the unit
5.5.4
3D image
1. Select the Standard (A), high resolution (B) or endo program (C). Endo program is only for 61 x 41 mm FOV.
A
B
C
2. Select mA.
WARNING!
Close the patient positioning mirror before taking
any exposures.
3. Press and hold down the exposure button. During the exposure you hear an audible signal and the exposure
warning symbol on the ClearTouch™ control panel appears.
4. Select SMAR™ ON or OFF based on your estimation of
the need. See chapter 3.4.1. SMAR™, SOREDEX® Metal Artifact Reduction.
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5.5.5
Stone model and radiographic guide
scan
For scanning of stone models and radiographic guides, a
positioning plate is available for the system.
1. Scan the patient with an open bite by securing the bite
with cotton pads.
2. Install positioning plate. Position stone model.
Note! It is recommended to use a sponge or a foam
under radiographic guide during the scan.
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5 Using the unit
3. Take scout image with default values. Correct position if
needed.
4. Select same resolution and parameters as in patient
scan.
Note! More detailed instructions in the CRANEX® 3D Quick
Guide Stone model and radiographic guide scan protocol.
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5.6 Warnings and error messages
The unit responds to error situations by showing a dialog
box containing an error code and descriptive text on the
touch screen.
When an error code appears on the display the unit will
stop working and cannot be operated while the error code
is on the display. In less severe cases a warning message
will be displayed, leaving the unit operable.
5.6.1
Acknowledging errors
Most errors may be acknowledged by closing the dialog
box the error is reported in. Some errors require the unit to
be rebooted. If such an error occurs, or if the unit fails to
operate as described in the user's manual, switch the unit
off, wait a few seconds and switch the unit on again.
5.6.2
Image transfer errors
If an image is not transferred successfully to the PC, close
and then reopen the dental imaging software and/or restart
the PC. DO NOT restart the unit as this will erase any
image that is stored in the unit memory and this retrievable
image will be lost. If restarting the PC and/or restarting the
dental imaging software does not allow you to retrieve the
images, contact technical support without restarting the
unit.
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6
Troubleshooting
High quality images with sharp contrast and good detail
provide optimum diagnostic information. Images with less
quality are usually the result of one or more common
problems.
6.1 Patient positioning
Problem
Incisors and canines
narrow and unsharp.
Overshadow in molar and
premolar areas. Rows of
teeth are compressed.
Possible cause
Remedy
1. Focal trough light set too
far posterior
2. Image layer laser light not
obeyed
3. Bite block was not
used
1. Check patient
positioning with
laser light lines and
occlusion correction
buttons
2. Check patient
positioning with laser
light lines and occlusion
correction buttons
3. Insert bite block
AUP
Problem
Possible cause
Incisors and canines wide
and unsharp. Rows of
teeth widened.
1. Focal trough light set too
far anterior
2. Image layer laser light
not obeyed
3. Bite block was not
used
ABACK
206718 rev 5
SOREDEX
Remedy
1. Check patient
positioning with laser
light lines and
occlusion correction
buttons
2. Check patient
positioning with laser
light lines and
occlusion correction
buttons
3. Insert bite block
75
6 Troubleshooting
Problem
Possible cause
Remedy
Teeth appear wider on one
side and narrower on the
opposite. Ramus widths are
different on opposite sides.
1. Midsagittal
line
not
obeyed
2. Patient's head not in
center position
1. Check patient's mid sagittal plane with laser light
line
2. Check that patient's
head is centered, and
that the head support
side clamps where
closed to keep the head
straight.
Problem
Possible cause
Remedy
The shadow of hard palate is
exposed over maxillary molars. Row of teeth has a
wavy appearance. TM joints
are exposed outward. Image
is not "smiling". Mandible is
imaged sharper than maxilla.
Patient head tilted back
Check FH plane
AUP
Problem
Rows of teeth curved upwards. Mandibular incisors
are unsharp. TMJ joints exposed high and are often cut
off from the image. Image is
"smiling" too much.
76
Possible cause
Patient head tilted forward
SOREDEX
Remedy
Check FH plane
206718 rev 5
6 Troubleshooting
Problem
Possible cause
Middle area of the image too
bright and unsharp. Spine
shadow.
Patient's neck was not
stretched
Remedy
Stretch patient's neck
ANECK
Problem
Possible cause
Remedy
Black shadow over maxillary
teeth apex area.
Tongue was not against the
roof of palate.
Ask patient to swallow
and place tongue against
the roof of palate during
the exposure.
Problem
Possible cause
Remedy
TMJ's exposed on different
heights on image. Bilateral
distortion in molar and premolar regions.
1. Patient tilted to one side
2. Midsagittal laser light line
not obeyed.
1. Check
midsagittal
plane and center patient's head.
2. Check
midsagittal
plane and center patient's head.
Problem
Possible cause
Remedy
Rows of teeth exposed too
high. TMJ's cut off.
1. Chin was not resting on
chin support
2. Patient positioned too high
1. Check patient positioning and type of bite
fork rod.
2. Check patient positioning and type of bite
fork rod.
Problem
Possible cause
Rows of teeth exposed too
low. Mandible not exposed
completely to the image.
Chin rest was not used with
bite fork.
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Remedy
Install chin rest.
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6.2 Image appearance
Problem
Images are too light
Problem
Images are too dark
Problem
Lack of image contrast
78
Possible cause
Remedy
1. SCANORA®: Contrast and
brightness not optimum
2. SCANORA®: Gamma not
set correctly
1. Adjust
contrast
and
brightness.
2. Select a more fitting histogram type and check
gamma setting.
Possible cause
1. SCANORA®: Contrast and
Remedy
brightness not optimum.
2. Manual technique factors
used too high.
1. Adjust contrast and density.
2. Decrease technique factors.
Possible cause
Remedy
1. SCANORA®: Contrast and
brightness not optimum.
2. kV used is too high.
3. Gamma value is not correct for the monitor being
used.
1. Adjust
contrast
and
brightness.
2. Lower the kV setting.
3. Adjust Gamma value
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6.3 Artefacts
Problem
Possible cause
Remedy
Irregular, bright shadows or
artefacts
Patient is wearing metal objects, such as earrings, necklace etc.
Ask patient to remove objects.
Possible cause
Remedy
AJEWEL
Problem
An unexposed area is shown
down in the lower middle section of the image.
Lead apron misplaced.
Check the lead apron positioning.
AAPRO
Problem
Possible cause
Partial lack of detail and motion artefacts. Irregular vertical bright lines on image.
Patient has moved during the
exposure.
Remedy
Problem
Possible cause
Remedy
Vertical dark lines on image.
Patient's shoulder in touch
with machine parts.
Check patient positioning.
Retake the image.
Problem
Possible cause
Patient's right side tooth are
not exposured.
Exposure button released
prematurely.
Problem
Possible cause
Remedy
Right and left image sides
are uncomplete. TMJ's are
not shown.
TMJ areas in sectional images where deselected.
Select all sections in panoramic image.
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Remedy
Retake the image.
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Problem
Possible cause
Remedy
A light horizontal line on QA
image.
Bite block was left on place.
Remove the bite block
and retake QA image.
Problem
Possible cause
Remedy
Horizontal lines on image.
Sensor problem.
Problem
Possible cause
CEPH: Lateral view has 2 ear
holder pins.
1. Cephalostat
lock
not
locked
2. Ear holders misaligned
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Consult the dealer.
Remedy
1. Lock it
2. Call service
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6.4 Unit operation
Problem
Possible cause
Remedy
Back of the patient's head
is touching the x-ray tube
during the exposure.
1. Patient's head inclination
not correct
2. Patient is too big for the
unit.
3. Patient has slumped.
If the image is not acceptable then
1. Check the head position
and retake the image.
2. Check the patient positioning. Make the exposure even though the
head may touch the tube
head.
3. Check the patient positioning. Make the exposure even though the
head may touch the tube
head.
Problem
Possible cause
Remedy
Patient's shoulders are
touching the x-ray tube or
sensor.
Patient is too big for the unit.
Wide and high shoulders.
Reverse patient's hands on
handles: left to right side
handle and vice versa.
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Maintenance
7.1 Maintenance procedure
The maintenance procedure described below shall be seen
as a minimum requirement and can be made more
stringent to comply with regulations regarding the use and
maintenance of dental x-ray devices that are in force in the
country in which the unit is installed.
7.1.1
Annual maintenance
An annual maintenance procedure must be carried out at
least once a year by qualified service personnel. Contact
your local distributor for details.
7.1.2
Calibration intervals
To keep the image quality at best possible level,
calibrations and quality checks shall be carried out at
regular intervals according to the table below.
Modality
Minimum requirement
Recommendation
3D
Two (2) times annually
Four (4) times annually
Panoramic
Annually during normal maintenance
Two (2) times annually
Cephalometric
Annually during normal maintenance
Two (2) times annually
Note! The calibrations mentioned in this manual can be
done by the user or qualified service personnel.
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7.2 Changing the fuses
Main fuses are located next to the on/off power switch.
Push inward on the fuse base and twist it counterclockwise
with a screwdriver. The fuse with the base comes out.
Remove the fuse from the base and replace it with the new
one. Repeat this with each blown fuse. Fasten both fuses
by pushing the base in and twisting it clockwise with a
screwdriver.
Use only appropriate fuses:
•
Line voltage 220-240 Vac: 326 Littelfuse 10A
(slow blow) or Cooper Bussman MDA-10
(time delay)
•
Line voltage 100-120 Vac: 326 Littelfuse 15A
(slow blow) or Cooper Bussman MDA-15
(time delay)
7.3 Cleaning and decontaminating the unit
CAUTION!
Switch the unit off or disconnect it from mains
before cleaning the unit. If you use a spray cleaner
do not spray into any ventilation grills. Do not allow
water or other cleaning liquids to enter the unit
interior since these may cause short-circuits or
corrosion. The unit should be cleaned after every
usage.
CAUTION!
Clean the dust off the unit regularly. The unit might
overheat if excess dust is gathered on the cooling
grilles.
Unit surfaces
All surfaces can be wiped clean with a soft cloth dampened
with a mild detergent, e.g. soapy water. DO NOT use
abrasive cleaning agents or polishes on this equipment.
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Positioning light covers
The positioning light covers are made of clear plastic. Use
a soft cloth dampened with a mild detergent, e.g. soapy
water. NEVER use abrasive cleaning agents or polishes to
clean the covers.
Surfaces that the patient touches
All surfaces and parts that the patient touches or comes
into contact with must be decontaminated after each
patient. Use a disinfectant that is formulated specifically for
decontaminating dental equipment and use the disinfectant
in accordance with the instructions supplied with the
disinfectant. All items and surfaces should be dried before
next usage.
Note! Wear gloves and other protective equipment during
decontamination process. In accordance with the instructions supplied with the cleaner.
WARNING!
Do not use any disinfecting sprays since the vapor
could ignite causing injury.
Decontamination techniques for both the unit and the room
must comply with all laws and regulations within the local
jurisdiction.
Examples of cleaning agents that can be found in
disinfectant products which are allowed or prohibited when
cleaning the unit:
Allowed: Methanol (metyl alcohol), Soap, Isopropyl
alcohol, distilled water.
Not allowed: Bentzene, Chlorine bentzene, Acetone,
Acetic ether, agents containing phenol, paracetic acid,
peroxide and other oxygen-cleaving agents, sodium
hypochlorite and iodine-cleaving agents.
Autoclave
Some removable parts in contact with the patient may be
autoclaved. These parts are: bite rods, bite guides and chin
supports.
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7 Maintenance
If autoclaving is performed for these items, disinfection by
alternate methods is not needed.
Steam sterilization
Recommended parameters for sterilizable parts are:

Gravity-displacement steam sterilization
"Flash" sterilization:
Temperature: 270 F (132°C)
Exposure time: 3 minutes

Prevacuum steam sterilization
"Flash" sterilization:
Temperature: 270 F (132°C)
Exposure time: 3 minutes

Steam-flush pressure-pulse steam sterilization
Temperature: 270 F to 275 F (132°C to 135°C)
Exposure time: 3 to 4 minutes
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Calibration and adjustment
8.1 Introduction
Calibrations and quality checks are performed by taking
exposures of calibration tools. The system does needed
adjustments according to the image data captured. For
panoramic and cephalometric quality checks the quality is
visually evaluated by the operator.
Resulting from the each calibration is an image containing
calibration results, telling the operator how to proceed with
the calibration and adjustment procedure. In addition to the
calibration name (e.g. Adjustment panCol) the images
contain image data sampled during the calibration,
adjustment instructions and a "Passed / Not Passed /
Failed" calibration status.
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Passed means that the calibration program is successfully done. Move on to next calibration.
-
Not passed means that adjustment is still needed.
Follow the instructions the image (if any) and take
another exposure. Some calibration programs are
iterative and demand a few repetitions.
-
Failed means that the system could not decide
what adjustment should be done in order for the
calibration to succeed. This calibration status is always the result of some error condition. Taking another exposure will not help. The image may give a
hint on what the problem is (e.g. no radiation, collimator severely tilted, image data corrupted…).
Contact service if the problem persists after restarting the unit and PC.
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8.2 Preparing for calibration
1. Close the head support and lock it in its upmost position.
2. Switch the PC and unit on.
3. PC: Open the dental imaging software and then open a
patient (card) and give it and identifiable name, for example: calibration (refer to the user’s manual supplied with
the dental imaging software for more information).
4. PC: Click the image acquisition button to activate image
capture.
5. Touch the settings button on the touch screen display.
6. Select the Quality assurance button.
The calibration display appears.
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8.3 Panoramic calibration
8.3.1
Panoramic geometry calibration
1. Select the program.
2. Press Return.
3. Install the double cone calibration tool.
4. Take an exposure.
5. Repeat the calibration until calibration result “passed” is
achieved.
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8.3.2
Panoramic pixel calibration
Note! The pixel calibration results are sensor specific. If the
x-ray unit is equipped with separate panoramic and cephalometric sensors, the cephalometric sensor cannot be used
for panoramic imaging without re-calibration (and vice versa).
Note! Re-do panoramic pixel calibration, if cephalostat
sensor is moved to panoramic side or the sensor is
changed.
1. Remove the calibration tools.
2. Select the program.
3. Press Return.
4. Take an exposure.
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8.3.3
Panoramic Quality Check (optional)
Note! Use the same tool for cephalostat Quality Check.
1. Attach a panoramic Quality Check Tool (optional) to the
chin support.
2. Select the Pan QC program.
3. Press Return.
4. Take an exposure.
5. Visually evaluate the result using the installed imaging
software.
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8 Calibration and adjustment
2
3
1
4
5
Subjects to be evaluated:
1. Smoothness of the exposed area. Non-exposed area surrounds the whole
image.
2. High contrast resolution; minimum 3.1LP/mm must be distinguishable.
3. All four low contrast holes must be visible.
4. Roundness of the ball.
5. The ball should be placed symmetrically between the two pins. The distance
from both pins to center should be equal length.
Note! The panoramic QC collimator is equipped with a 0.8
mm copper filter. If more filtration is required, additional filtration may be attached to the tubehead cover. The unit
may be configured to use higher exposure values to compensate for an additional 1 mm copper filter.
Ask Technical Support to adjust the copperthickness setting
as required.
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8.4 3D calibration
8.4.1
3D geometry calibration
1. Attach the base of the phantom to the lower shelf.
Level it with the bubble.
2. Select the program.There is a calibration procedure for
both 3D imaging modes, standard and high resolution.
Standard geometry calibration has to be done first.
3. Press Return.
4. Install the 3D calibration phantom.
5. Take an exposure.
6. Repeat the calibration until calibration result “passed” is
achieved. This calibration is only needed with 3D units.
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8.4.2
3D pixel calibration
1. Remove the 3D calibration phantom.
2. Select the program.
3. Press Return.
4. Take an exposure. The result image informs when the
calibration is passed.
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8.4.3
3D Quality Check program
1. Attach the QC phantom to the unit.
2. Select the 3D QC program.
3. Press Return.
4. Take an exposure.
5. Review, with 3D viewing software from the axial view by
scrolling the slices the info about calibration result. The
resulting image contains information on whether the
quality check was passed. Repeat until quality check is
passed.
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8.5 Cephalometric calibration
8.5.1
Ceph pixel calibration
Note! The pixel calibration results are sensor specific. If the
x-ray unit is equipped with separate panoramic and cephalometric sensors, the cephalometric sensor cannot be used
for panoramic imaging without re-calibration (and vice versa).
Note! Re-do panoramic pixel calibration, if cephalostat
sensor is moved to panoramic side or the sensor is
changed.
1. Rotate the ear holders into PA view position and move
them completely apart. Turn nasion support up out of the
way.
2. Select Ceph Pix program.
3. Press Return.
4. Take an exposure.
5. This calibration should always be a pass.
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8 Calibration and adjustment
8.5.2
Ceph Quality check program
(Optional)
1. Attach the QC phantom to the ceph unit and ensure that
it’s leveled from the spirit level.
2. Select the Ceph QC program.
3. Press Return.
4. Take an exposure.
5. Visually evaluate the result using the installed imaging
software.
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1
3
2
Subjects to be evaluated:
1. Smoothness of the exposed area. Non-exposed area surrounds the whole
image.
2. High contrast resolution; minimum 3.1LP/mm must be distinguishable.
3. All four low contrast holes must be visible.
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Technical data
9.1 Technical specifications
Manufacturer
SOREDEX, PaloDEx Group Oy
Nahkelantie 160 (P.O. Box 148)
FIN-04300 Tuusula, FINLAND
Quality system
In accordance with ISO13485 and ISO9001 standard
Environmental
management system
In accordance with ISO14001 standard
Conformity to standards:
IEC 60601-1: 1988 and A1+A2
IEC 60601-1-1: 2000
IEC 60601-1-4: 1996 and A1
IEC 60601-2-7: 1998
IEC 60601-2-28: 1993
IEC 60601-2-32: 1994
IEC 60601-1-2: 2001 and A1
IEC 60601-1-3: 1994
UL 60601-1: 2003
CAN/CSA –C22.2 No. 601-1-M90 and S1+A2 standards
This product complies with DHHS 21 CFR Chapter I,
Subchapter J at the date of manufacture.
CRANEX® 3D is in conformity with the provisions of
Council Directive 93/42/EEC as amended by the Directive 2007/47/EC concerning medical devices.
Performance Standards and European Union Directive
93/42/EEC (Medical Devices Directive).
CRANEX® 3D
Product name
Model:
PP3-1
CRANEX® 3D
Product type:
Digital dental imaging system with panoramic,
cephalometric and Cone Beam 3D imaging programs.
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9 Technical data
Unit data
Protection against electric shock
Class I
Degree of protection
Type B applied with no conductive connection to the patient
Protection against the ingress of liquids
IP20
Disinfection methods
- mild soapy water (non-abrasive)
- non-alcohol based disinfectant for the chin rest
- disposable plastic covers for bite block, chin rest and
chin support
For use
In environments where no flammable anaesthics nor
flammable cleaning agents are present
Mode of operation
continuous operation/intermittent loading
Safety
IEC 60601-1
EMC Classification
Class B
Tube head assembly
Tube head assembly type
THA 300
Tube type
Toshiba D-052SB, D-054SB-C
Stationary anode
Tube voltage
57 - 90 kV
Max. tube current
16 mA
Max. electric output
1,44 kW
Target angle
5 degrees
Focal spot
0,5 x 0,5 mm (IEC 336/1982)
Nominal anode input
1750 W
Reference axis
In the middle of the panoramic sensor´s active area
Max. anode heat content
35 kJ
Max. X-ray tube assembly heat content
385 kJ
Max. continuous heat dissipation of
the X-ray tube assembly
38 W
Total filtration
>3,2 mm Al
Leakage Technique Factors
90 kV /4 mA
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Electrical connections
Nominal mains voltage
100 - 240 Vac (Selectable)
Input power frequency
50 / 60 Hz
Nominal current
10A @ 230 VAC, 15A @ 110 VAC
Fuses
230 Vac:
Littelfuse 326 (slow blow) 10A
Cooper Bussman (time delay) MDA-10
110 Vac:
Littelfuse 326 (slow blow) 15A
Cooper Bussman (time delay) MDA-15
Power consumption
2.3 kVA @ 230 VAC, 1.65 kVA @ 110 VAC
Maximum impedance of main
0,2 
Positioning laser lights
Panoramic, TMJ & Maxillary Sinus
Programs
laser light
(CLASS 1 LASER PRODUCT)
max output 100µW
Cephalostat FH laser light
3D imaging programs
Warning symbols are placed next to the laser lights and
the label describing the laser light classification is placed
inside the carriage side cabinet. USA / Canada models
have different types of laser light stickers according to local requirements.
Caution - use of controls or adjustments or performance
of procedures other than those specified herein may result in hazardous radiation exposure.
IEC 60825-1:1993+A1:1997+A2:2001
High frequency DC generator
Nominal power
1750 W nominal at 90 kV, 12 mA
Anode voltage
57 - 90 kV (+/- 5 kV)
Anode current
3,2 - 16 mA (+/- 1 mA)
Focal spot
0.5 mm
Minimum total filtration
3.2 mm Al
Supply frequency
75 - 150 kHz
Spine compensation
kV / mA compensated
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9 Technical data
User interface
Program and technique factors selection, exposure control
Touch screen panel, optional remote exposure switch
Patient positioning
Positioning panel, integrated
Connection cable
(CRANEX® 3D - PC)
CAT6 Ethernet cable
Panoramic programs & Technical factors & magnification:
Standard Adult Panoramic
57-90 kV/ 3.2-16 mA/16.4 s
30%
Child Panoramic
57-90 kV/ 3.2-16 mA/14.4 s
30%
TMJ PA
57-90 kV/ 3.2-16 mA/10.6 s
23%
TMJ Lateral
57-90 kV/ 3.2-16 mA/11.2 s
55%
Maxillary Sinus
57-90 kV/ 3.2-16 mA/12.5 s
30%
Bitewing (BW)
57-90 kV/ 3.2-16 mA/11.9 s
30%
Panoramic QC
57-90 kV/ 3.2-12.6 mA/16.4 s
30%
Exposure Control
Automatic Exposure Setting
based on patient head size
(AES)
Cephalometric programs & Technical factors:
Reduced width lateral view
85-90 kV / 8-12.6 mA / 6.9-14 s
Full width lateral
85-90 kV / 8-12.6 mA / 10-20 s
PA/AP, facial and oblique views
80-90 kV / 8-12.6 mA / 10-20 s
Carpus program (optional)
(Not in USA and Canada)
60-90 kV / 3.2-12.6 mA / 8-20 s
Exposure Control
Automatic Exposure Setting (AES) based on patient
head size
Magnification factor
1.15 (15%)
3D imaging programs:
XS FOV dimensions
61 x 41 mm (HxD)
Midi FOV (optional)
dimensions
61 x 78 mm (HxD)
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3D imaging programs:
XS FOV standard
resolution
90 kV / 6.3 - 12.5 mA / 2.3 s
Midi FOV (optional)
standard resolution
90 kV / 6.3 - 12.5 mA / 4.9 s
XS FOV High resolution and
Endo program
90 kV / 4 - 12.5 mA / 6.1 s
Midi FOV (optional) High
resolution
90 kV / 4 - 10 mA / 12.6 s
XS FOV scout
90 kV / 4 - 12.5 mA / 0.02 s
Midi FOV (optional) scout
90 kV / 4 - 12.5 mA / 0.04 s
Image storing and retrieving:
File formats
PNG (16-bit), JPG (12-bit)
File compression
PNG (lossless),
JPG (100%-60% quality)
Typical panoramic file size
About 2-4 MB (PNG 16 bits)
Typical cephalometric file size
3-5 MB (PNG 16 bits)
Typical 3D file size
150-250 MB (DICOM)
Patient database
Standalone workstation
Server on local area network (LAN)
Panoramic patient positioning
Operation
Left
Motorised carriage movement
Positioning aids
Chin rest, bite block, 3-point headrest
Hinged mirror, 3 positioning laser
lights, Y-layer step less adjustment
Cephalostat patient positioning
Operation
Arm mounts on left or right side of the unit Interlocked
pan/ceph sensor
Motorised carriage buttons at cephalostat head assembly.
Positioning aids
Ear holders, Nasion support with vertical mm scale,
Frankfort horizontal plane laser light, Contact plate (Carpus program).
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9 Technical data
3D imaging patient positioning
Operation
Left or right side of unit
Motorised carriage movement
Positioning aids
Chin rest, chin support, chin cup
3-point headrest, hinged mirror,
3 positioning laser lights
Cephalostat scanning
Scanning method
Horizontal scan, synchronized sensor and secondary slot
motion
Scanning time
10 - 20 s.
Panoramic image receptor
Sensor unit
Pan sensor or interchangeable Ceph sensor
Technology
CMOS
Image pixel size and depth
100 x 100 m and 14 bits
Active area height
5.8 inches / 148 mm / 1480 pixels
Resolution
Pan: 5 LP/mm
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Cephalometric image receptor
Sensor unit
interchangeable Ceph sensor
Technology
CMOS
Image pixel size and depth
100 x 100 m and 14 bits
Active area height
223,2 mm / 2232 pixels
Image field width in lateral view
10.2 inches / 260 mm, maximum
6.7 inches / 170 mm, minimum
Image field width in PA view
7.9 inches / 200 mm
Resolution
4 LP/mm (cephalometric)
3D image receptor
Sensor unit
3D sensor
Technology
CMOS Flat panel
Image pixel size and depth
200 m and 13 bits
Active sensor surface
(H x W)
100 x 68 mm
Unit physical measures:
source-image distance (SID)
500 mm (Panoramic)
570 mm (3D)
Installation
Standard wall mount with ±45° angled joint.
Optional base for free standing unit (unit height is increased 25 mm).
Height x Width x Depth (inches/mm)
2414x965x1126mm (standard column)
94.9 x 38 x 44.3 inches -Max.
Weight
200 kg / 440 lbs. (Panoramic)
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9 Technical data
CRANEX® 3D ceph physical measures:
source-image distance (SID)
68.7 inches / 1745 mm
source-object distance (SOD)
60 inches / 1520 mm
Installation
Standard wall mount with 45° angled joint. Optional base
for free standing unit (unit height is increased 25 mm)
Height x Width x Depth (inches/mm)
2414 x 1872 x 1126 mm
94.9 x 73.7 x 44.3 inches
Weight
250 kg / 551 lbs. (Cephalometric)
Ambient temperatures:
Transportation and Storage
-10°…+60°C
Operation Temperature
+10°...+35°C, RH max. 85%
Minimum PC requirements for 3D acquisition workstation
Processor
2.5 GHz dual core, or better
Memory
3 Gigabytes RAM, or more
Hard disk
500 GB, or more
Expansion slot
PCI-Express bus for supplied GPU,
full length
Power supply
500 watt minimum
Network
Gigabit Ethernet 1000Base-T
Operating system
Windows 7 or Windows Vista
(32 or 64-bit)
Display
20" LCD display, 1600 x 1200 or
22" LCD widescreen display,
1680 x 1050, or better
Standard
The PC must meet the IEC 60950 standard (minimum requirements)
Graphics board
The system is highly dependent on the used graphics
board and graphics driver of the reconstruction workstation. Consult technical support for information on the supported boards and drivers. Examples of supported
boards:
NVidia Quadro 4000
NVidia GeForce GTX 560
The compatible graphics driver versions are found on the
driver update DVD.
PCI board connection
Full-length PCIe x16 slot
(for GPU board)
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Minimum PC requirements for 3D acquisition workstation
USB
USB ports (for HASP Dongle keys)
• 1 for reconstruction system
• 1 for 3D viewing SW (if needed)
Mouse
Mouse with scroll wheel
Minimum PC requirements for 2D acquisition workstation *
Processor
2.5 GHz dual core, or better
Memory
3 Gigabytes RAM, or more
Hard disk
500 GB, or more
Graphics board
NVidia GeForce 6600 or
ATI Radeon X700 or better;
256MB or more memory
(integrated graphics are not supported)
Power supply
500 watt minimum
Network
Gigabit Ethernet 1000Base-T
Operating system
Windows 7 or Windows Vista
(32 or 64-bit)
Display
20" LCD display, 1600 x 1200 or
22" LCD wide screen display,
1680 x 1050, or better
Standard
The PC must meet the IEC 60950 standard (minimum requirements)
Mouse
Mouse with scroll wheel
OpenCL support
OpenCL 1.1 supported by either processor or graphics
adapter
* These requirements are valid only if driver update 11.4 or
later is used. For earlier versions see table Minimum PC
requirements for 3D acquisition workstation.
Note! This is an abbreviated list of requirements.
Please refer to the software installation manual or contact
your local dealer for detailed installation requirements.
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Minimum PC requirements for 2D/3D Viewing workstation *
Processor
2.0 GHz dual core, or better
Memory
2 Gigabytes RAM, or more
Graphics board
NVIDIA GeForce 6600 or
ATI Radeon X700 or better;
256MB or more memory
(integrated graphics are not supported)
Hard disk
3 GB free space, or more
Network
Gigabit Ethernet 1000Base-T
(recommended) or Fast Ethernet
100Base-TX
Operating system
Windows 7 or Windows Vista
(32 or 64-bit)
Display
19" LCD display, 1280 x 1024, or better
* For the PC requirements of the 3D viewing software
consult the 3D software manuals.
System requirements and connections
110
-
The PC and any other external device(s) connected to the system must meet the IEC 60950 standard (minimum requirements). Devices that do not
meet the IEC 60950 standard must not be connected to the system as they may pose a threat to operational safety.
-
The PC and any other external devices must be
connected in accordance with IEC 60601-1-1.
-
The x-ray unit must be connected to it’s own separate power supply. The PC and any other external
devices must NOT be connected to the same power supply as the x-ray unit.
-
Position the PC and any other external device at
least 1.5 m (60”) from the xray unit so that the patient cannot touch the PC or any other external device while being x-rayed.
-
The PC and any other external devices shall not be
connected to an extension cable.
-
Multiple extension cables shall not be used.
-
Do not position the PC where it could be splashed
with liquids.
-
Clean the PC in accordance with the manufacturer’s instructions.
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Ceph ready option (Ordered separately)
Options
Description
Ceph Upgrade to CRANEX® 3D pan
Upgrade CRANEX® 3D panoramic with Cephalometric
imaging.
Field upgrades for model CRANEX® 3D
Upgrade
Description
Cephalostat Upgrade
Add ceph imaging to CRANEX® 3D pan
3D XS or MIDI FOV Upgrades
Add 3D option to CRANEX® 3D
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9.2 Unit dimensions
Note! The cephalostat arm and the touchscreen can be on
either side (L/R).
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9.3 Symbols that appear in the unit
Radiation warning
Dangerous voltage
On or enabled
Off or disabled
Exposure switch
Connector for exposure switch
CLASS II equipment
(Double insulated electrical appliance)
Ethernet connector
Operating instruction
(More details in operation instructions)
Laser radiation
Attention, consult accompanying documents
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Ground (Functional)
Protective ground
Laser class label (Patient positioning lights)
This symbol indicates that the waste of electrical
and electronic equipment must not be disposed
as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information
concerning the decommissioning of your equipment.
Type B equipment
CE (0537) symbol
MDD 93/42/EEC
ETL Classified conforms to UL STD 60601-1.
Certified to CSA.
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9.4 Labels on the unit
The main label of the unit is located on the vertical carriage
next to the on/off power switch. The unit is class I, type B
and with IP20 protection.
Type:
PP3 - 1
Ser. No:
Manufactured:
10 A 220 - 240 V~ 50 / 60 Hz (1A continuous)
15 A 100 / 120 V~ 50 / 60 Hz (1A continuous)
This product complies with DHHS 21 CFR Chapter I,
Subchapter J at the date of manufacture.
Rx only.
Warning:
This X-ray unit may be dangerous to patient
and operator unless safe exposure factors,
operating instructions and maintenance
schedules are observed.
Manufactured by Soredex
Nahkelantie 160
FI-04300 TUUSULA, Finland
206718 rev 5
SOREDEX
D502470
ETL CLASSIFIED
CONFORMS TO UL STD 60601-1.
CERTIFIED TO CSA
STD C22.2 NO 601.1.
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9 Technical data
9.5 Electromagnetic Compatibility (EMC)
tables
Note! Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to
EMC information.
Table 1.1 Electromagnetic emissions IEC 60601-1-2 Ed2
CRANEX® 3D is suitable for use in the specified electromagnetic environment. The purchaser or user of CRANEX® 3D should assure that it is used in an electromagnetic environment as described below:
Emissions Test
Compliance
Electromagnetic Environment
Radio-Frequency
Emissions
CISPR11
Group 1
CRANEX® 3D uses RF energy only for its internal function. Therefore, the RF emission is very low and not likely
to cause any interference in nearby electronic equipment.
Radio-Frequency
Emissions
CISPR11
Class B
CRANEX® 3D is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
CRANEX® 3D is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Complies
CRANEX® 3D is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
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Table 1.2 Electromagnetic immunity IEC 60601-1-2 Ed2
CRANEX® 3D is suitable for use in the specified electromagnetic environment. The purchaser or user of CRANEX® 3D should assure that it is used in an electromagnetic environment as described below:
Immunity Test
IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment
Electrostatic discharge (ESD)
IEC 61000-4-2
± 2, 4, 6 kV for
contact discharge
± 2, 4, 8 kV for air
discharge
± 2, 4, 6 kV for
contact discharge
± 2, 4, 8 kV for air
discharge
Floors are wood, concrete, or ceramic tile, or floors are covered with
synthetic material and the relative
humidity is at least 30 percent.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 2 kV for power
supply lines
Mains power quality is that of a typical commercial and/or hospital environment
± 1 kV for
input/output
lines
± 1 kV for
input/output
lines
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common
mode
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality is that of a typical commercial and/or hospital environment.
Voltage dips,
short interruptions and voltage variations
on power supply
input lines
IEC 61000-4-11
< 5 % UT
(> 95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(> 95 % dip in UT)
< 5 % UT
(> 95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(> 95 % dip in UT)
Mains power quality is that of a typical commercial and/or hospital environment. If the user of CRANEX® 3D
requires continued operation during
power mains interruptions, it is recommended that CRANEX® 3D be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields are
at levels characteristic of a typical location in a typical commercial and/or
hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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Table 1.3 RF immunity of non-life-support equipment or
system IEC 60601-1-2
CRANEX® 3D is suitable for use in the specified electromagnetic environment. The purchaser or user of CRANEX® 3D should assure that it is used in an electromagnetic environment as described below:
Immunity
Test
IEC
60601-1-2
Test Level
Compliance
Level
Electromagnetic
Environment
Portable and mobile RF communications equipment
are used no closer to any part of CRANEX® 3D, including cables, than the recommended separation
distance calculated from the equation appropriate for
the frequency of the transmitter.
Recommended Separation Distance:
Conducted
RF IEC
61000-4-6
3 V150 kHz
to80 MHz
[ V1 ] 3 V
Radiated
RFIEC
61000-4-3
3 V/m80
MHz to2,5
GHz
[ E1 ] 3 V/m
d =[
3,5
] P
V1
d =[
3,5
] P
E1
d =[
7
E1
] P
80 MHz to 800 MHz
800 MHz to 2,5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).Field strengths from fixed RF
transmitters, as determined by an electromagnetic
site survey,* are less than the compliance level in
each frequency range.** Interference may occur in
the vicinity of equipment marked with the following
symbol:
*Field strengths from fixed transmitters, such as base stations for cellular telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be estimated
accurately. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be performed. If the measured field strength exceeds the RF compliance level above, observe CRANEX® 3D to verify normal operation in each use location. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating CRANEX® 3D.
**Over the frequency range 150 kHz to 80 MHz, field strengths are less than [V1] V/m.The Recommended Separation Distances are listed in the next table.Note: These guidelines may not
apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
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Note! RF communications equipment can effect medical
electrical equipment.
Note! This equipment generates, uses and can radiate radio frequency energy. If not installed and used in accordance with this manual, it may cause harmful interference to
radio communications. Portable and mobile RF communications equipment can also affect the performance of
CRANEX® 3D.
Table 1.4 Table 4
Recommended Separation Distances
for Portable and Mobile RF Communications Equipment
IEC 60601-1-2
Frequency of
Transmitter
150KHz to
80 MHz
d =[
3,5
] P
80 MHz to
800 MHz
d =[
3,5
] P
800 MHz to
2,5 GHz
d =[
7
] P
V1
E1
E1
Separation
Distance
(meters)
Separation
Distance
(meters)
Separation
Distance
(meters)
0,01
0,12
0,12
0,23
0,1
0,37
0,37
0,74
1
1,17
1,17
2,34
10
3,69
3,69
7,38
100
11,67
11,67
23,34
Equation
Rated
Maximum
Output
Power of
Transmitter
(watts)
USE LIMITATION:
External components
The use of accessories, transducers, and cables other
than those specified may result in degraded
ELECTROMAGNETIC
COMPATIBILITY
of
the
EQUIPMENT and/or SYSTEM
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INSTALLATIONS REQUIREMENTS & ENVIRONMENT
CONTROL:
In order to minimize interference risks, the following
requirements shall apply.
Cables shielding & grounding
All interconnect cables to peripheral devices must be
shielded and properly grounded. Use of cables not
properly shielded and grounded may result in the
equipment causing radio frequency interference.
Electrostatic discharges environment & recommendations
In order to reduce electrostatic discharge interference, a
charge dissipative floor should be installed to prevent
charge accumulation.
■
■
The dissipative floor material must be connected to
the system reference ground, if applicable.
Relative humidity must be maintained above 30
percent.
Stacked components & equipment
The CRANEX® 3D should not be used adjacent to or
stacked with other equipment; if adjacent or stacked use is
necessary, the CRANEX® 3D should be observed to verify
normal operation in the configuration in which it will be
used.
Interference may occur in the vicinity of equipment
marked with the following symbol:
No portable or mobile RF communications equipment may
be used closer to any part of the CRANEX® 3D, including
cables, than the recommended separation distance
calculated from the equation appropriate to the frequency
of the transmitter.
See Table 4.
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9.6 X-ray tube assemblies
Duty cycle 1:8
Rectification type: Constant pot ential x-ray generator
Generator rating: Generator nominal power 1750W
Figure 1.3
Anode Thermal Characteristics
35
225W
HEAT STORAGE [kJ]
30
175W
25
20
15
10
COOLING
5
HEATING
0
0
2
4
6
8
10
TIME [min]
Figure 1.4
Maximum Rating Charts
(Absolute maximum rating charts)
DC (Center-Grounded)
Focal Spot : 0.5 mm
25
70kV
TUBE CURRENT [mA]
80kV
60kV
90kV
20
50kV
100kV
15
10
5
1
2
3
5
7
10
20
EXPOSURE TIME [s]
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Figure 1.5
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